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Compassionate Use Study of Pergolide in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00624741
Expanded Access Status : No longer available
First Posted : February 27, 2008
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
This compassionate use study is designed to monitor safety in patients who have been doing well on pergolide therapy, wish to continue treatment, and have not been able to tolerate alternative treatments.

Condition or disease Intervention/treatment
Parkinson Disease Drug: Pergolide

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Study Type : Expanded Access
Official Title: Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease

Intervention Details:
  • Drug: Pergolide
    Pergolide tablets should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.
    Other Name: Permax

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Diagnosed with Parkinson's disease and treated successfully with pergolide in the recent past
  • Attempt to taper off pergolide was unsuccessful and patient was unable to change to other forms of therapy for Parkinson's disease
  • No evidence of cardiovalvular disease by echocardiogram conducted within 60 days prior

Exclusion Criteria:

  • History or current diagnosis of cardiac valvulopathy
  • Inability to undergo echocardiograms every 6 months while receiving pergolide
  • Hypersensitivity to pergolide or other ergot derivatives

No Contacts or Locations Provided
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00624741    
Other Study ID Numbers: PRG-001
First Posted: February 27, 2008    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by Bausch Health Americas, Inc.:
Parkinson's disease
Compassionate use
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs